EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE

Latex Patient Examination Glove

YTY INDUSTRY (MANJUNG) SDN. BHD.

The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Evergreen Non-sterile Powdered Latex Examination Glove.

Pre-market Notification Details

Device IDK974191
510k NumberK974191
Device Name:EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE
ClassificationLatex Patient Examination Glove
Applicant YTY INDUSTRY (MANJUNG) SDN. BHD. 198 AVENUE DE LA D'EMERALD Sparks,  NV  89434 -9550
ContactMoh Ung Nang
CorrespondentLeonard Frier
MET LABORATORIES, INC. 914 WEST PATAPSCO AVE. Baltimore,  MD  21230
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received1997-11-10
Decision Date1997-12-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.